PDS Biotech initiates Phase 3 trial for HPV16-positive head and neck cancer with positive updates

From GlobeNewswire: 2025-05-14 07:30:00

PDS Biotech has initiated their VERSATILE-003 Phase 3 clinical trial for HPV16-positive head and neck cancer, with Mayo Clinic sites joining the trial. Abstracts on Versamune® HPV were selected for the 2025 ASCO Annual Meeting. FDA cleared an IND application for a new combination therapy for colorectal cancer. The Company also announced financial results for the first quarter of 2025, showing a net loss of $8.5 million.

Research and development expenses for the quarter were $5.8 million, while general and administrative expenses were $3.3 million. Total operating expenses were $9.1 million, with a cash balance of $40 million as of March 31, 2025. A conference call and webcast will be held today at 8:00 a.m. Eastern Time for further updates.

PDS Biotech is focused on immunotherapy to target and kill cancers, with ongoing clinical trials and collaborations. The Company’s lead investigational therapy Versamune® HPV is being developed in combination with other treatments. Forward-looking statements have been made regarding the Company’s plans and expectations for the future. For more information, visit their website.

Financial tables detailing the Company’s operating expenses, interest income, net loss, and selected balance sheet data for the first quarter of 2025 have been provided. Cash and cash equivalents were reported at $39.9 million, with total assets of $47 million. The Company’s long term debt, accumulated deficit, and total stockholders’ equity were also disclosed in the report.



Read more at GlobeNewswire:: PDS Biotech Reports First Quarter 2025 Financial Results